Targeting Sarcopenia and Frailty: Multicomponent Exercise With Focal Muscle Vibration

NCT07049809 | Completed

• 1 other identifier: 01-24-175-116
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy of multicomponent exercises (aerobic exercises, strength exercises, and balance exercises), individualized with the application of a focal muscle vibration machine at the lower extremities, on parameters of sarcopenia (a muscle disease) in health-related physical fitness, physical performance, frailty levels, and cognitive function, falls, and hospitalizations in older adults. Focal muscle vibration is a type of therapeutic technique used with the application of six capsules placed on the lower extremities, three on each bed, each of which generates a tolerable vibration depending on the stimulation of the muscles. It is neither painful nor counterproductive to the muscles in the lower extremities. Multicomponent exercises refer to the application of exercises through three different modalities: aerobic exercises, strength exercises, and balance exercises. We alternate these three types of exercises to achieve millions of health benefits. The multi-component program will be individualized based on each individual's abilities to avoid risks and achieve maximum benefits.

Conditions

Sarcopenia; Frailty at Older Adults; Cognitive Impairment; Adherence

Keywords

sarcopenia; frailty; older adults; cognition; focal vibration; multicomponent exercise

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery

  Short Physical Performance Battery (SPPB) is a standardized test that evaluates Balance, Gait speed and Lower limb strength (via chair stands). Has a total puntuaction of 12 points: 0-3: Severe physical limitation, 4-6: Moderate limitation, 7-9: Mild limitation, 10-12: Good physical function. The SPPB (Short Physical Performance Battery) is closely related to sarcopenia because it assesses physical function, which is one of the key diagnostic criteria for sarcopenia.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (6)

• Demographic and anthropometric assessments

  from enrollment to 12 weeks after treatment

• Handgrip

  from enrollment to 12 weeks after intervention

• SARC-F

  from enrollment to 12 weeks after intervention.

• Clinical Frailty Scale

  from enrollment to 12 weeks after intervention

• Muscle ultrasound

  from enrollment to 12 weeks after intervention.

Study Arms (2)

Combination Intervention group

EXPERIMENTAL

2-month intervention. 3 days/week. 30 minutes/day. Will receive a multicomponent program based on aerobic training, resistance training and balance training, combined with focal muscle vibration. Of the 3 days of weekly intervention, 1 day will be aerobic exercise combined with focal muscle vibration, 1 day resistance exercise with focal muscle vibration and 1 day of balance exercise with focal muscle vibration. The combined program will be individualized based in the intrinsic capabilities of each individual.

Combination Product: Focal Muscle Vibration; Other: Multicomponent Exercise

Multicomponent Exercise Group

ACTIVE COMPARATOR

3-month intervention. 3 days/week. 30 minutes/day. Will receive a multicomponent program based on aerobic training, resistance training and balance training. The combined program will be individualized based in the intrinsic capabilities of each individual.

Other: Multicomponent Exercise

Interventions

Focal Muscle Vibration COMBINATION_PRODUCT

The focal vibration machine will be used. The device has 6 muted transducers that generate power between 30-300 Hz, but for this study we will use between 100-150 Hz for 30 minutes. The application of the 6 transducers or heads is at the level of the lower extremities, since those muscle groups present the most clinical correlation with functional parameters such as gait and balance. 3 transducers will be placed on one leg (vastus medialis, vastus lateralis and rector anterior) and the other 3 transducers on the other leg, on the same muscles. To speed up the intervention program and cover more participants, 4 focal vibration machines will be used. Each participant wil use 1 machine and 6 transducers, so during the 30 minutes that the intervention lasted, the groups will be of 4 participants with t

Combination Intervention group

Multicomponent Exercise OTHER

The program consists of a multi-component approach, integrating aerobics, resistance, and balance training. The weekly schedule include three intervention days: one day focused on aerobic exercise, one day dedicated to resistance training and one day centered on balance training. The combined program is individualized based on the intrinsic capabilities of each individual.

Combination Intervention group; Multicomponent Exercise Group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• people over 75 years of age,
• score ≥18 on the Mini-Mental State Exam (MMSE)
• score on the Clinical Frailty Scale between 1-6
• be institutionalized
• ability to sit unassisted on a chair or in a wheelchair

You may not qualify if:

• progressive degenerative diseases
• uncontrolled symptomatic cardiovascular or respiratory disease
• current cancer under treatment
• severe audiovisual impairment

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, Spain

Location

Related Publications (2)

• Cordes T, Bischoff LL, Schoene D, Schott N, Voelcker-Rehage C, Meixner C, Appelles LM, Bebenek M, Berwinkel A, Hildebrand C, Jollenbeck T, Johnen B, Kemmler W, Klotzbier T, Korbus H, Rudisch J, Vogt L, Weigelt M, Wittelsberger R, Zwingmann K, Wollesen B. A multicomponent exercise intervention to improve physical functioning, cognition and psychosocial well-being in elderly nursing home residents: a study protocol of a randomized controlled trial in the PROCARE (prevention and occupational health in long-term care) project. BMC Geriatr. 2019 Dec 23;19(1):369. doi: 10.1186/s12877-019-1386-6.

  PMID: 31870314 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Cognitive Dysfunction; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist. Professor at the department of Medicine.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: July 2, 2025
• Primary Completion: September 26, 2025
• Study Completion: December 15, 2025
• Last Updated: May 4, 2026

Record last verified: 2025-07

Locations

ES (1)